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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePAS CHAMPION(TM) CATHETER 30 MM LONG BALLOONS
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantProgressive Angioplasty Systems, Inc.
1350 Willow Rd.
Suite 201
Menlo Park, CA 94025
PMA NumberP930012
Supplement NumberS004
Date Received06/27/1996
Decision Date11/18/1996
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF THE FOLLOWING BALLOON SIZES TO BE ADDED TO THE PAS CHAMPION(TM) PTCA CATHETER LINE: 2.5MM X 30MM; 3.0MM X 30MM; AND 3.5MM X 30MM
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